Data / Medical devices / Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125)
Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125) (LTK): 19 FDA-registered makers in 5 countries
19 establishments in 5 countries are registered with the FDA to make Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125) (product code LTK, Class 2, 21 CFR 866.6010). 13 of them have a 510(k) clearance or PMA approval on file and 3 have a recall event. The FDA has issued 26 510(k) clearances under this code, the latest on May 10, 2024, and lists 6 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- LTK
- Device class
- 2
- Regulation
- 866.6010
- Medical specialty
- Immunology
Makers by country
| Country | Makers |
|---|---|
| United States | 10 |
| Japan | 4 |
| United Kingdom | 2 |
| Germany | 2 |
| Ireland | 1 |
Makers of Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125)
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Beckman Coulter, Inc. | Chaska, MN, United States | Manufacturer | 2 | May 10, 2024 | 0 | 0 | 0 | api.fda.gov |
| Siemens Healthcare Diagnostics Products Limited | LLANBERIS Wales, United Kingdom | Manufacturer | 2 | September 8, 2023 | 0 | 0 | 0 | api.fda.gov |
| Siemens Healthcare Diagnostics Inc. | Tarrytown, NY, United States | Complaint file establishment, Specification developer | 2 | April 6, 2020 | 0 | 1 | 0 | api.fda.gov |
| Siemens Healthcare Diagnostics Inc. | E Walpole, MA, United States | Manufacturer | 2 | April 6, 2020 | 0 | 2 | 0 | api.fda.gov |
| ABBOTT GmbH | Wiesbaden Hesse, Germany | Specification developer | 1 | November 19, 2004 | 0 | 0 | 0 | api.fda.gov |
| Fujirebio Diagnostics, Inc. | Seguin, TX, United States | Manufacturer | 1 | May 21, 2015 | 0 | 0 | 0 | api.fda.gov |
| Fujirebio Inc. | Sagamihara-shi Kanagawa, Japan | Manufacturer | 1 | May 21, 2015 | 0 | 0 | 0 | api.fda.gov |
| Fujirebio Inc. Ube Facility | Yamaguchi, Japan | Manufacturer | 1 | May 21, 2015 | 0 | 0 | 0 | api.fda.gov |
| Ortho-Clinical Diagnostics, Inc. | Rochester, NY, United States | Complaint file establishment, Specification developer | 1 | December 12, 2022 | 0 | 1 | 0 | api.fda.gov |
| Ortho-Clinical Diagnostics | Pencoed Bridgend, United Kingdom | Manufacturer | 1 | December 12, 2022 | 0 | 0 | 0 | api.fda.gov |
| Roche Diagnostics GMBH | MANNHEIM Baden-Wurttemberg, Germany | Manufacturer | 1 | August 6, 2015 | 0 | 0 | 0 | api.fda.gov |
| Siemens Healthcare Diagnostics Inc. | Newark, DE, United States | Manufacturer | 1 | April 12, 2011 | 0 | 0 | 0 | api.fda.gov |
| Tosoh Aia, Inc. | Toyama, Japan | Manufacturer | 1 | December 6, 2002 | 0 | 0 | 0 | api.fda.gov |
| Epitope Diagnostics, Inc. | San Diego, CA, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Fujirebio Diagnostics, Inc. | Malvern, PA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Monobind, Inc. | Lake Forest, CA, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Otsuka Electronics Co., Ltd. | Koka-city Shiga, Japan | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Scientific Supplies & Technology, Inc. | Doral, FL, United States | Remanufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Siemens Healthcare Diagnostics Manufacturing Ltd. | SWORDS Dublin(County), Ireland | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated May 10, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.